MAUDE Adverse Event Report: MEDTRONIC XOMED INC. N/A; STIMULATOR, NERVE

Model Number	9450003
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: no analysis results are available, the device was not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that following a metrix decompression with emg monitoring via nim and electrodes, "when staff was removing the needle electrodes it was noticed that one needle had broken off and was under the skin in the muscle of the patient, confirmed w xray." fragment remains in the extensor hallucis longus.There was no patient injury.Additional information received stating that for the procedure the electrode was "bent at a 90 degree angle to insert and to reduce the chance of the plastic tip being pulled out of the skin." when the fragment was discovered the physician had planned on removing it, however, the patient chose to leave it in.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: N/A
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6322011
• Report Number: 1045254-2017-00053
• Device Sequence Number: 442669
• Product Code: ETN
• UDI-Device Identifier: 00721902572715
• UDI-Public: 00721902572715
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K031003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 9450003
• Device Catalogue Number: 9450003
• Device Lot Number: 0212383567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 59